|
Device | BELLAFILL |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | SUNEVA MEDICAL, INC. 5879 PACIFIC CENTER BLVD. SAN DIEGO, CA 92121 |
PMA Number | P020012 |
Supplement Number | S008 |
Date Received | 08/16/2013 |
Decision Date | 08/27/2013 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A CHANGE IN THE TRADE NAME OF YOUR PRODUCT FROM ARTEFILL® TO BELLAFILL®. |